Norm

NEN-EN-ISO 5840-2:2015 en

Cardiovasculaire implantaten - Hartklepprothesen - Deel 2: Chirurgisch geïmplanteerde vervangende hartkleppen

161,21

Over deze norm

Status Definitief
Aantal pagina's 55
Commissie Chirurgische implantaten
Gepubliceerd op 01-10-2015
Taal Engels
NEN-EN-ISO 5840-2 is applicable to heart valve substitutes intended for implantation in human hearts, generally requiring cardiopulmonary bypass and generally with direct visualization. This part of ISO 5840 is applicable to both newly developed and modified surgical heart valve substitutes and to the accessories, packaging, and labelling required for their implantation and for determining the appropriate size of the surgical heart valve substitute to be implanted. This part of ISO 5840 outlines an approach for qualifying the design and manufacture of a surgical heart valve substitute through risk management. The selection of appropriate qualification tests and methods are derived from the risk assessment. The tests may include those to assess the physical, chemical, biological, and mechanical properties of surgical heart valve substitutes and of their materials and components. The tests may also include those for pre-clinical in vivo evaluation and clinical evaluation of the finished surgical heart valve substitute. This part of ISO 5840 defines performance requirements for surgical heart valve substitutes where adequate scientific and/or clinical evidence exists for their justification. For novel surgical heart valve substitutes, e.g. sutureless, the requirements of both this International Standard and ISO 5840-3 might be relevant and shall be considered as applicable to the specific device design and shall be based on the results of the risk analysis. This part of ISO 5840 excludes heart valve substitutes designed for implantation in artificial hearts or heart assist devices. This part of ISO 5840 excludes homografts.

Details

ICS-code 11.040.40
Nederlandse titel Cardiovasculaire implantaten - Hartklepprothesen - Deel 2: Chirurgisch geïmplanteerde vervangende hartkleppen
Engelse titel Cardiovascular implants - Cardiac valve prostheses - Part 2: Surgically implanted heart valve substitutes
Vervangt
Normatieve verwijzingen
  • 93/42/EEG, Medische hulpmiddelen

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